Coronary vein leads having pre-formed biased portions for fixation

ABSTRACT

A lead having a pre-formed biased portion is adapted for implantation with a body vessel and for connection to a signal generator. The lead is constructed and arranged so that when it is implanted, the electrodes are biased toward a vessel wall by the preformed biased portion, which operates to fixate the lead against the vessel wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/608,402, filed Oct. 29, 2009, which is a continuation of U.S. patentapplication Ser. No. 10/128,997, filed Apr. 23, 2002, now U.S. Pat. No.7,628,801, which is a continuation-in-part of U.S. patent applicationSer. No. 09/651,340, filed on Aug. 30, 2000, now U.S. Pat. No.6,584,361. This application is also a continuation-in-part of U.S.patent application Ser. No. 11/600,807, filed Nov. 16, 2006, which is adivisional of U.S. patent application Ser. No. 10/431,136, filed on May7, 2003, now U.S. Pat. No. 7,139,614, which is a continuation of U.S.patent application Ser. No. 09/651,340, filed on Aug. 30, 2000, now U.S.Pat. No. 6,584,362. Each of these applications are incorporated hereinby reference in their entirety for all purposes.

TECHNICAL FIELD

The present subject matter relates to the field of leads for correctingirregularities of the heart. More particularly, this subject matterrelates to an atraumatic tip assembly for leads for pacing and/orsensing the heart from the coronary vasculature.

BACKGROUND

A cardiac pacing system includes a battery powered pulse generator andone or more leads for delivering pulses to the heart. Current pulsegenerators include electronic circuitry for determining the nature of anirregular rhythm, commonly referred to as arrhythmia, and for timing thedelivery of a pulse for a particular purpose. The pulse generator istypically implanted into a subcutaneous pocket made in the wall of thechest. Leads which are attached to the pulse generator are routedsubcutaneously from the pocket to the shoulder or neck where the leadsenter a major vein, usually the subclavian vein. The leads are thenrouted into the site of pacing, usually a chamber of the heart. Theleads are electrically connected to the pulse generators on one end andare electrically connected to the heart on the other end. Electrodes onthe leads provide the electrical connection of the lead to the heart,where the leads deliver the electrical discharges from the pulsegenerator to the heart.

The electrodes are typically arranged on a lead body in two ways orcategories. A pair of electrodes which form a single electrical circuit(i.e., one electrode is positive and one electrode is negative)positioned within the heart is a bipolar arrangement. The bipolararrangement of electrodes requires two insulated wires positioned withinthe lead. When one electrode is positioned in or about the heart on alead and represents one pole and the other electrode representing theother pole is the pulse generator, this arrangement is known as aunipolar arrangement. The unipolar arrangement of electrodes requiresone insulated wire positioned within the lead.

Some patients require a pacing system having multiple sites in onechamber of the heart for detecting and correcting an abnormal heartbeat.In the past, a common practice for a patient requiring multi-site pacingwithin one or more chambers of the heart, would be to provide twoseparate and different leads attached to the particular chamber of theheart. One lead would be implanted at one site in the chamber. Anotherlead would be implanted at another site in the same chamber, or anotherchamber. Typically, the single chamber of the heart receiving multi-sitepacing would be the right atrium.

Having two separate leads is undesirable for many reasons. Among theseare the complexity of and time required for the implantation procedurefor implanting two leads as compared to that of the procedure forimplanting one lead. In addition, two leads may mechanically interactwith one another after implantation which can result in dislodgement ofone or both of the leads. In vivo mechanical interaction of the leadsmay also cause abrasion of the insulative layer along the lead which canresult in electrical failure of one or both of the leads. Anotherproblem is that as more leads are implanted in the heart, the ability toadd leads is reduced. If the patient's condition changes over time, theability to add leads is restricted. Two separate leads also increase therisk of infection and may result in additional health care costsassociated with re-implantation and follow-up.

It is well understood that the heart functions with two sides. The rightside of the heart receives blood from the body and pumps it into thelungs to exchange gases. The left side of the heart receives theoxygenated blood from the heart and pumps it to the brain and throughoutthe body. As currently practiced, endocardial pacing and defibrillationleads are positioned within the right chambers of the heart, since theleft side pumps blood to the brain. Furthermore, numerous difficultiesare encountered when it is desired to sense and pace the left heartendocardially.

Accordingly, there is a need for a endocardial lead that can reliablyperform pacing and sensing of the heart without being placed in the leftside of the heart.

SUMMARY

A lead assembly includes a lead body adapted to carry electricalsignals, where the lead body has a proximal end and a distal end, and anintermediate portion therebetween, and a connector is located at theproximal end of the lead body. At least one conductor is disposed withinthe lead body, and the lead body has at least one preformed biasedportion at an intermediate portion of the lead body. The lead furtherincludes an unbiased, flexible tapered portion disposed between thebiased portion and the distal end of the lead body, and the taperedportion distal to the biased portion is substantially more flexible thanthe biased portion. The lead further includes at least one electrodecoupled with at least one conductor.

Several options for the lead are as follows. For instance, in oneoption, the unbiased, flexible tapered portion terminates at the distalend of the lead body. In another option, the conductor forms an innerlumen therein, and the inner lumen is isodiametric. In another option,none of the conductors extend to the distal end of the lead body, whereoptionally the conductor terminates within the unbiased, flexible,tapered portion of the lead body. In yet another option, the biasedportion has a helical shape, and optionally electrodes are disposedalong the helical shape, wherein the electrodes on the helical shape arespaced 120 degrees apart. The lead includes, in another option,radiopaque material molded within material forming the unbiased,flexible, tapered portion.

In another embodiment, a lead assembly includes a lead body adapted tocarry signals, such as an open lumen lead, where the lead body extendsfrom a proximal end to a distal end, and has an intermediate portiontherebetween. The lead body has at least one preformed biased portion atan intermediate portion of the lead body, and at least one conductor isdisposed within the lead body. A flexible portion and, optionally, atapered portion are included near the distal end of the lead body, wherethe flexible portion is more flexible than the biased portion. Thedistal end of the lead body has a tapered portion adapted to beimplanted within a passage.

Several options for the lead are as follows, for instance, in oneoption, the flexible portion extends from the distal tip, oralternatively, from the distal tip to a portion between the bias and thedistal tip, or in another option, the flexible portion extends fromdistal tip to the preformed biased portion. In another option, thetapered portion extends from distal tip to a portion between thepreformed biased portion and the distal tip. In yet another option, theflexible portion has a length greater than the tapered portion.

Several other options are also possible. For example, the conductor doesnot extend to the distal tip, or the biased portion has a helical shape,where electrodes are optionally spaced about 120 degrees apart aroundthe helical shape. In yet another option, the distal end of the leadbody includes a premolded tip assembly filled with radiopaque material.

In another embodiment, a method includes placing a guidewire within oneor more passageways of a body, and threading a lead assembly over theguidewire. The lead assembly includes a lead body adapted to carrysignals, where the lead body has a proximal end and a distal end, and anintermediate portion therebetween. The lead assembly further includes aconnector located at the proximal end of the lead body, and at least oneconductor is disposed within the lead body. The lead body has at leastone preformed biased portion at an intermediate portion of the leadbody, and a flexible portion and a tapered portion are disposed betweenthe biased portion and the distal end of the lead body. The taperedportion is distal to the biased portion and is more flexible than thebiased portion. The method further includes biasing one or moreelectrodes against a wall of at least one of the passageways, andplacing the distal end in a cardiac vein.

Several options for the method are as follows. For instance, in oneoption, the method further includes viewing the distal tip assemblyunder fluoroscopy, where the lead assembly includes a distal tipassembly including a premolded portion filled with radiopaque material.In another option, the method further includes flexing the distal end ofthe lead body. Optionally, biasing the electrodes against the wall ofthe passageway includes positioning one or more electrodes around ahelical portion of the lead body.

The above described leads advantageously provide the ability to senseand pace the heart using leads positioned within the cardiacvasculature, and further the leads provide the ability to pace and/orsense the left heart. It has been found that by placing a therapeuticlead near the atrium, but not in the atrium, higher amplitudeelectrograms may be detected as compared to a standard endocardial lead.Further, it has been found that left sided pacing may help suppressatrial arrhythmias, particularly those originating near the left atrium.Still further, it has been found that the ability to critically controlthe timing between pacing the atria and ventricles of the heart is ofutility in optimizing pacing therapies.

The leads described herein involve geometries that facilitatepositioning the lead assembly within the vasculature, and further helpinsure that an optimally positioned lead will remain in that positionwell beyond the time of implant. The lead designs discussed herein yieldreliable and optimal performance in sensing and pacing of the heart.

The lead advantageously allows for effective use of a biased portion ona lead body in combination with an atraumatic tip assembly. The biasedportion allows for gentle and effective forces against passage wallsenabling the lead to be positionally maintained therein. In addition,the biased portion ensures the electrode is placed up against thepassage wall with sufficient force. The spacing of the electrodes alongthe biased portion provides for an increased opportunity for theelectrode to be placed against the passage wall. The atraumatic tipassembly is extremely flexible, relative to the biased portion, whichallows for improved maneuverability of the lead through tortuousvasculature, and allows for the lead to be implanted more easily andquickly than conventional leads. Furthermore, the flexible taperedportion of the atraumatic tip assembly allows for the guidewire orstylet, if used, to better guide the lead without interference from thebiased portion.

These and other embodiments, aspects, advantages, and features of thepresent invention will be set forth in part in the description whichfollows, and in part will become apparent to those skilled in the art byreference to the following description of the invention and referenceddrawings or by practice of the invention. The aspects, advantages, andfeatures of the invention are realized and attained by means of theinstrumentalities, procedures, and combinations particularly pointed outin the appended claims and their equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of a coronary vein lead constructed in accordancewith one embodiment;

FIG. 1B is a side view of a coronary vein lead constructed in accordancewith another embodiment;

FIG. 2 is an enlarged view of the lead of FIG. 1A, taken along circle2-2 of FIG. 1A;

FIG. 3A is side view of a coronary vein lead constructed in accordancewith one embodiment, shown positioned in a coronary vein;

FIG. 3B is side view of a coronary vein lead constructed in accordancewith another embodiment, shown positioned in a coronary vein;

FIG. 3C is side view of a coronary vein lead constructed in accordancewith another embodiment, shown positioned in a coronary vein;

FIG. 4A is a side view of a coronary vein lead constructed in accordancewith one embodiment;

FIG. 4B is a side view of a coronary vein lead constructed in accordancewith one embodiment;

FIG. 4C is a side view of a coronary vein lead constructed in accordancewith one embodiment;

FIG. 4D shows lengths and diameters of a coronary vein lead constructedin accordance with one embodiment;

FIG. 4E shows radii of a coronary vein lead constructed in accordancewith one embodiment;

FIG. 5A is a side view of a portion of a coronary vein lead constructedin accordance with one embodiment;

FIG. 5B is an end view of a coronary vein lead constructed in accordancewith one embodiment;

FIG. 5C is a side view of a portion of a coronary vein lead constructedin accordance with one embodiment;

FIG. 5D is a side view of a portion of a coronary vein lead constructedin accordance with one embodiment;

FIG. 6A is a side view of a coronary vein lead constructed in accordancewith one embodiment;

FIG. 6B is a side view of a coronary vein lead constructed in accordancewith one embodiment;

FIG. 6C is an enlarged cross section of a portion of the lead as shownin FIG. 6B;

FIG. 6D is an enlarged cross section of a portion of the lead as shownin FIG. 6B;

FIG. 6E is an enlarged cross section of a portion of the lead as shownin FIG. 6B;

FIG. 6F is an enlarged cross section of a portion of the lead as shownin FIG. 6B;

FIG. 6G is an enlarged cross section of a portion of the lead as shownin FIG. 6B;

FIG. 7 is a side view of a coronary vein lead constructed in accordancewith one embodiment;

FIG. 8 is a side view of an electrode constructed in accordance with oneembodiment of the coronary vein lead;

FIG. 9 is a side view of a coronary vein lead constructed in accordancewith one embodiment;

FIG. 10A is a side view of a coronary vein lead constructed inaccordance with one embodiment;

FIG. 10B is a side view of a coronary vein lead constructed inaccordance with one embodiment;

FIG. 11 illustrates a side elevational view of a portion of a lead withan atraumatic tip constructed in accordance with one embodiment;

FIG. 12 illustrates a side elevational view of a portion of a lead withan atraumatic tip constructed in accordance with one embodiment;

FIG. 13 illustrates a cross-sectional view of a portion of a lead withan atraumatic tip constructed in accordance with one embodiment.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that other embodiments may be utilized and that structuralchanges may be made without departing from the scope of the presentinvention. Therefore, the following detailed description is not to betaken in a limiting sense, and the scope of the present invention isdefined by the appended claims and their equivalents.

FIG. 1A is a side view of one example of a coronary vein lead 100. Thelead 100 has a proximal end 102 and a distal end 104 and includes aconnector terminal 110 and a lead body 120. The lead 100 attaches to apulse sensor and generator 140. In one embodiment, the lead 100 isconstructed and arranged for insertion into the coronary sinus, asdiscussed further below. The lead body 120 has a number of electrodes122 in its distal end 104 which is implanted in a coronary vein. Theconnector terminal 110 electrically connects the various electrodes andconductors within the lead body 120 to a pulse sensor and generator 140.The pulse sensor and generator 140 contains electronics to sense variouspulses of the heart and also produce pulsing signals for delivery to theheart. The pulse sensor and generator 140 also contains electronics andsoftware necessary to detect certain types of arrhythmias and to correctfor them.

The lead 100, in one option, operates similarly to a bipolar lead havingpositive and negative portions of a circuit located in the lead body120. It should be noted that this lead may also be made a unipolar lead.In other words, one electrode or both electrodes of the lead body 120can be pacing/sensing electrodes, or one electrode can be apacing/sensing electrode and the anode can be the pulse generator.

The lead body 120, in one option, is a tubing material formed from apolymer biocompatible for implantation, and preferably the tubing ismade from a silicone rubber polymer. Alternatively, the lead body 120may be made of a biocompatible material having shape memorycharacteristics such that it will return to its preformed shape onceimplanted and a stylet or guidewire is removed. An example of such amaterial is polyether polyurethane. In addition, the lead body 120optionally has portions which have shape memory characteristics,comprising either a shape memory polymer or a shape memory metal. Thelead body contains several electrical conductors. The electricalconductors are made of a highly conductive, highly corrosion-resistantmaterial. The electrical conductors carry current and signals betweenthe pulse sensor and generator 140 and the electrodes located at thedistal end 104 of the lead 100. Electrical conductors are shown, forexample, at 472 and 473 of FIGS. 4B and 4C, and at 672 and 673 of FIGS.6C, 6E and 6G.

The lead body 120 optionally has a helical portion 130 near the distalend 104. The helical portion 130 includes a three-dimensional biasadapted to bias at least a portion of the lead body 120 or electrodeagainst a wall of a passage, as further discussed below. Afterimplantation into a patient, in one option, the helical portion 130 willbe located in a coronary vein, as shown, for example, in FIG. 1B.Referring to FIG. 1B, a coronary vein 124 is shown which includes a freewall 126 and a myocardial wall 128. The free wall 126 is faced away froman inner portion of the heart 125, and the myocardial wall 128 abuts theinner portion of the heart.

The helical portion 130 of the lead body 120 is optionally made of abiocompatible material having shape memory characteristics such that itwill return to its preformed helical shape once implanted and a styletor guidewire is removed. An example of such a material is polyetherpolyurethane. In addition, the lead body may have portions which haveshape memory characteristics, comprising either a shape memory polymeror a shape memory metal. The diameter of the helical shape is, in oneoption, about 0.25 cm-2 cm. The pitch of the helix, in one option,ranges from 0.5 cm-2.5 cm. It should be noted that the helical shape canbe formed by any number of turns, including, but not limited to,multiple turns, a single turn, or less than one turn.

As mentioned above, the helical portion 130 includes electrodes 122. Inone option, the electrodes 122 are evenly spaced at about 120 degreesapart, which increases the opportunity for the electrodes 122 to makecontact with the myocardial wall 128. In a further option, pairs ofelectrodes 122 are evenly spaced about 120 degrees apart along the leadbody 120. The electrodes 122 are electrically coupled with oneconductor, or are electrically coupled with separate conductors.

The helical portion 130 of the lead body 120 facilitates placement ofthe electrodes against the myocardial wall 128 of the coronary vein 124during and/or after implantation. The helical shape of the lead 100provides large lead/vessel wall area interface to produce reliable, longterm stability. When implanted, the helical shape of the lead 100produces subtle lateral forces between the electrodes 122 and myocardialwall 128, resulting in low pacing thresholds.

Referring to FIGS. 1A and 2, the distal end 104 of the lead 100 includesseveral electrodes 122, and in one example has two electrodes 132, 134.The first electrode 132 is generally referred to as the distalelectrode. A second electrode 134 is located near the distal electrodeand proximally thereof and can be used as a counter electrode forelectrode 132 or for defibrillation therapy. The lead 100 maybegenerally described as a tachycardia (tachy) lead, although it is notlimited thereto. The electrodes 132, 134 are of an electricallyconductive material such as an alloy of platinum and iridium which ishighly conductive and highly resistant to corrosion. The electrodes 132,134 optionally include a passive fixation portion. Electrodes 132 and134 are masked or otherwise insulated on the inside radius 142 of thedistal end 104 of the lead 100. This decreases electrode area andprovides desired increase in impedance. The bipolar electrode pairspacing between electrodes 132 and 134 is shown at line A of FIG. 2 tobe from about 1-5 mm. With such close electrode spacing, increasedrejection of problematic far field (ventricular) signals isaccomplished. Optionally, the electrode surfaces 136, 138 are raisedbeyond the body 120 of the lead 100. Electrodes designed in this fashionincrease the chances of achieving intimate tissue-electrode contactthereby resulting in lower thresholds.

FIG. 3A shows an alternative embodiment of a coronary vein lead 200which has a helical distal end 230, where the heart 10, left ventricle22, right ventricle and apex 24 of the heart 10 are shown. It should benoted that the helical distal end 230 includes any of the abovediscussed helical configurations, and can be combined with any of theembodiments discussed below. The left coronary artery 25 branches intothe circumflex artery 26 and the anterior descending artery 27. Thecoronary sinus 28 branches into the coronary branch vein 29. Placing thelead 200 in the coronary branch veins, for example, on the leftventricle has been found to be a suitable means for delivering pacingtherapy to patients suffering from congestive heart failure, withouthaving to position the lead 200 within the left ventricle.

Referring to FIG. 3B, the lead 200 is adapted to be used within thecoronary artery 25 and also within the coronary branch vein 29. Acoronary vein lead 200 with a helical distal end 230 is shown located inan implanted site. The coronary vein lead 200 includes a mid ventricularelectrode pair 246 (electrodes 232 and 234). The electrodes 232, 234 areshown in intimate contact with the vessel wall 108 of the branch vein29, where the electrodes 232, 234 contact the myocardial wall, asdiscussed above. The coronary vein lead 200 optionally includes a midventricular electrode pair 246 (electrodes 232 and 234) and furtheroptionally includes an apical electrode pair 250 (electrodes 252 and254). The helical portion 230 and the spacing of the electrodespositions the electrodes 232, 234 against the myocardium to reducepacing thresholds. The helix diameter is such that a vein of any sizewill reduce the diameter of the helix so that at least one electrodewill be pressed against the myocardial wall. The lead 200 optionally hasa fixation mechanism 240, as shown in FIGS. 3A and 3C.

In one embodiment shown at FIG. 3B, multiple smaller electrodes 232,234, 242, 244 are strategically placed along the helix 230 therebyincreasing the probability of direct electrode contact on the myocardialwall of the vein versus the free wall. For example, multiple electrodesare spaced apart along the helix 230 to span from the apex 24 to thebase 18 of the heart 10. Electrodes 232, 234 form a midventricularelectrode pair 246 and electrodes 242, 244 form a basal electrode pair248, so designated by their proximity to a particular region of theheart when the lead 200 is in its implanted site in the heart 10. In oneembodiment, lead 200 has an apical electrode pair 250 formed ofelectrodes 252, 254 which have a proximity to the apex 24 of the heart10 when implanted. The portion of the lead 200 including the apicalelectrode pair 250 optionally includes a helical portion. In anotheroption, instead of pairs, single electrodes, or more than two electrodescan be included in that discussed above.

In an embodiment where multiple electrodes are connected to the sameconductor, the electrode with the best tissue contact will serve as thestimulating electrode. In one embodiment, the lead 200 has multipleelectrodes and conductors, and the electrodes which are the cathodes oranodes are selected depending on the thresholds acquired at eachstimulation site. As an example, in a bipolar lead, optimal therapy maybe achieved by choosing the tip or ring (such as are shown, for example,at 750 and 734 of FIG. 7) as cathode or anode depending on the differentthresholds. In the embodiments shown at FIGS. 3A and 3B, multipleelectrode capacity is provided in the left ventricular vein. Theseelectrodes are capable of pacing together, or alternatively with only apair of the electrodes pacing together. Further, the electrodesoptionally pace with a delay between them or sequentially.

Referring to FIG. 3C, a steroid is optionally used to ensure pacing atthe cathodal site. The steroid is located in close proximity of thecathode electrode, for example, electrode 234, and not in closeproximity of the anode electrode. The steroid is provided by way ofsteroid collar 256 loaded with the desired drug which is then timereleased. The steroid collar 256 is external to the lead body 220, andadjacent to the electrode. The drug has a very localized effect, therebyrequiring close proximity to the cathode. Steroid release in closeproximity to the anode electrode is not critical, but may be allowed.This placement of the steroid collar 256 ensures that the cathodeelectrode paces first, and before the anode electrode. An example ofsuch a drug is dexamethasone acetate. In another option, a steroidcollar or a steroid coating, for example, is provided as a generallycylindrical component adjacent one or both sides of an electrode of anylead described herein.

Another option for the leads described herein involves the use of localdrug elution, for example a steroid, in the vicinity of the electrodes.In many applications, desired low chronic pacing thresholds can beachieved through the local release of at least one pharmacologicallyactive agent. This can be easily accomplished by compounding agents intopolymeric components positioned adjacent to the electrodes. Apharmaceutical agent typically used in pacing applications is onepossessing anti-inflammatory action. Dexamethasone, dexamethasone sodiumphosphate and dexamethasone acetate have been used in commerciallyreleased devices. Other agents with other actions are other options. Forexample, steroidal anti-inflammatory agents other than dexamethasone,nonsteriod anti-inflammatory agents, as well as antiarrhythmic,antibiotic, anticoagulative, thrombolytic and other agents known toimprove biocompatibility and/or electrical therapies are optionallyused.

For steroid release to be therapeutic, it must occur in very closeproximity to the electrode. As such, in one embodiment, the steroid isreleased from the interior of an electrode and subsequently delivereddirectly to the heart tissue contacting the electrode. This isaccomplished by first compounding a biocompatible polymer (such assilicone) with a steroid substance (such as dexamethasone) and thenmolding the polymer-drug matrix into a small component than can finallybe positioned within a porous electrode. Alternatively, a polymer-drugmatrix is molded into a generally cylindrical component that can besubsequently positioned adjacent to one or both sides of a generallycylindrical electrode. Another alternative is to apply a thin coating ofthe polymer-drug matrix to the completed lead body construction inlocations consistent with the needed close proximity to the electrode.In yet another option, a steroid collar is used, as discussed above.

In one embodiment, the lead is constructed and arranged for fixation inthe coronary sinus. For example, the lead has specific biases tofacilitate placement and retention in passageways such as the coronarysinus. Referring now to FIG. 4A, a double-bias lead 400 constructed andarranged for fixation in the coronary sinus is shown. It should be notedthat the double-bias lead 400 can be combined with embodiments discussedabove and below. The lead 400 includes a first bias 402 and a secondbias 406, although an additional bias is optionally further providedwith the lead 400. The first bias 402 is disposed in a direction that isdifferent than the second bias 406, and in one option, the biases 402,406 lie in the same plane (i.e. 2-dimensions).

At FIG. 4A, a lead 400 is shown including half ring electrodes 432, 434which are biased against the vessel wall by a biased portion 460 of thelead 400. In one embodiment, the electrodes 432, 434 are spaced about 10mm apart along the lead 400, and the length of the biased portion 460 isabout 30 mm. In one embodiment, the lead 400 is constructed and arrangedso a first plane including a surface 438 of the electrode 434 is spacedabout 10 mm from a second plane including a surface 436 of the electrode432. The lead 400 in one embodiment is an over the wire lead with anopen distal end, as shown in FIG. 4B. A distal portion 404 near distalend 490 has a diameter of about 0.66 inch (5 French).

The lead 400, in one option, has a length which fits within the coronarysinus/great cardiac vein. The bias portion 460 pushes the electrode upagainst the vein wall. The bias portion 460 is constructed and arrangedto fit within the area of the coronary sinus/great cardiac vein aroundthe mitral valve. The lengths and diameters of the coronary sinus/greatcardiac vein are shown at FIG. 4D. The coronary sinus has a length ofabout 37 mm and the great cardiac vein has a length of about 43 mm, fora combined length of about 80 mm. The diameter of the proximal end ofthe coronary sinus at the thebesian valve is about 10 mm. Where thecoronary sinus and the great cardiac vein meet at the distal end of thecoronary sinus and the proximal end of the great cardiac vein at thevalve of vieussens, the diameter is about 5 mm. The distal portion ofthe great cardiac vein has a diameter of about 3 mm.

The mitral valve may have a radius (R) between about 9.5 mm-42 mm. Ingeneral the radius is about 30 mm. In one embodiment, the biased leadportion 460 shown at FIG. 4A has a radius between about 9.5 mm to about42 mm. In one embodiment, the biased portion has a radius of about 30mm. The biased portion 460 of lead 400 urges electrodes 432,434 againstthe vein wall. The diameter of the bias portion 460 of lead 400 isbetween electrodes 432 and 434, in one option, is larger than thediameter of the vein to provide a snug fit. In one embodiment thediameter is about 10 mm. Subtle lateral forces on vessel wall producereliable long term stability. Lateral forces between electrode andvessel wall result in low pacing thresholds. In one embodiment, thedistal end of the lead 400 has a diameter of about 0.066″.

Referring to FIG. 4B, in one embodiment the lead 400 has an atraumatictip 490 having an outer diameter of about 5 French (0.066 inch) and aninner diameter of about 0.038 inch. The interior space between coils 472has a diameter of about 0.018 inch. Atraumatic tip 490 in one embodimentcomprises silastic tubing extending beyond the coils 472 to avoidbruising the vasculature during implantation therein. At FIG. 4C thetransition 476 from a portion of lead body 420 which has two coils tothe distal portion having one coil 478 is shown. In one embodiment, thedistal portion having one coil 478 has an outer diameter of about 0.066inch. In one embodiment the distal portion 404 has a ring electrode 474.In one embodiment the lead has an outer diameter of about 0.067 inch atthe point where electrode 474 is located.

Because the lead 400 of FIG. 4A is designed to be implanted inside thecoronary sinus/great cardiac veins (CS/GCV), the size of the lead inrelation to the veins is very important. The leads described herein aredesigned to be held in place by wall tension, i.e. by the force of thelead against the heart wall. The lead 400 must be small enough to slideinto place and not damage the walls by excess forces. The lead bias orholding mechanism must not be too small or the lead 400 may becomedislodged and fall out. The biased portion 460 must not be too long orit will extend into the atrium. Referring to FIG. 4D, the length of thecoronary sinus and great cardiac veins together is 80 mm. If the pacingelectrodes are desired to sit in the middle of that vein when the tip490 of the lead 400 is located at the end of the great cardiac veins,the electrode should be placed about 43 mm proximal to the tip. Thediameter of the vein averages at 10 mm at the os (entrance) and goesdown to an average of 3 mm at the end of the great cardiac veins. Assuch, the intended position in the implanted site, or the final leadposition, is considered in the lead design so that in its final positionthe lead 400 is wedged or held in the appropriate place. The outerdiameter of the portion that is being wedged in place would be about 20to 30% larger than the inner diameter of the blood vessel. For example,referring to FIG. 4A, the dimension 462 of the biased portion 460 is 10mm. This would wedge into a portion of the vein that is about 7 mm indiameter, which is near the end of the coronary sinus near the beginningof the great cardiac veins.

In one embodiment, the lead body 420 may be made of a biocompatiblematerial having shape memory characteristics such that it will return toits preformed shape once implanted and a stylet or guidewire is removed.An example of such a material is polyether polyurethane. In addition,the lead body may have portions which have shape memory characteristics,comprising either a shape memory polymer or a shape memory metal.

FIGS. 5A-5D show a lead 500 constructed and arranged for fixation in thecoronary sinus, where the lead 500 includes any of the above and belowdiscussed leads. The silicone arches 540, in one option, are attached toand extend from a lead body 520 opposite the contact area 536 ofelectrode 532. The arches 540 provide spring forces to position theelectrode 532 against the vessel wall, and help to reduce dislodgementand keep pacing thresholds lower. The arches 540 also reducecomplications arising in the event that the lead 500 must be removed.Referring to FIG. 5C, in one option, the arch or arches 540 are part ofa molded part of the lead 500. In another option, as shown at FIG. 5D,the arches 540 are straight silicone rubber cylinders affixed to thelead body 520 wall by glue in two locations that force the cylinders toassume an arched configuration. Alternatively, molded components in theshape of an arch are positioned on the lead body 520, as shown at FIGS.5A and 5B.

The arches 540, in one option, straddle the electrode 532, as shown inFIGS. 5A, 5C, and 5D. In operation, any of the above mentioned arches540 provide a side thrust to the lead body 520 when that lead body 520is advanced into a narrow vessel with an inner diameter less than thecombined distance of the lead body outer diameter (d, as shown at FIG.5B) and the maximum height (h, as shown at FIG. 5B) of the arch. Theside thrust will force the electrode 532 against the vessel wall in aposition opposite of the arches 540. These arches 540 are provided toreduce the rate of two types of complications. First, duringimplantation of a lead body 520 having arches 540, that lead body 520could be manipulated back and forth in the vessel. Second, andconsistent with the first advantage, repositioning or removal of asubchronic or chronic lead will be easier than if the lead had freeended springs (like tines) entangling tissues when manipulation in atleast one direction is needed. In an alternative embodiment, the lead500 also comprises a helical portion as shown at FIGS. 1-2 and 3A-3C. Inone embodiment, the lead body 520 may be made of a biocompatiblematerial having shape memory characteristics such that it will return toits preformed shape once implanted and a stylet or guidewire is removed.An example of such a material is polyether polyurethane. In addition,the lead body may have portions which have shape memory characteristics,comprising either a shape memory polymer or a shape memory metal.

FIGS. 6A-6G show a lead 600 adapted for implantation and fixation in thecoronary sinus. It should be noted that lead 600, as well as the otherembodiments discussed above and below, are, in one option, chronicallyimplanted. FIG. 6A shows the entire lead 600, and FIGS. 6B-6G illustratea portion of the lead 600. The lead body 620 is generally shaped withthe same or smaller radius of curvature as the coronary sinus, so thatit hugs the anatomy of the coronary sinus when the lead 600 isimplanted. The shape of the lead body 620 hugging the myocardial wall ofthe coronary sinus urges the electrodes 632, 634 against the wall of thecoronary sinus. Because of this geometry compatibility, the lead 600will have good long term stability with relatively small forces on thelead body 620 and vessel walls. By distributing forces along the extentof the lead body 620, the possibility of lead or vessel wall damage isreduced. FIG. 6B shows the distal portion of one embodiment of lead 600in greater detail.

The radii of curvature and angles along different portions of the leadbody are shown. In one option, the lead body 620 is made of abiocompatible material having shape memory characteristics such that itwill return to its preformed shape once implanted and a stylet orguidewire is removed. An example of such a material is polyetherpolyurethane. In addition, the lead body may have portions which haveshape memory characteristics, comprising either a shape memory polymeror a shape memory metal. In another option, the lead body 620 ispreformed such that is has a shape adapted to hug the heart while thelead 600 is disposed in the coronary sinus. It should be noted that thehugging shape of the lead body 620 can be combined with any of the aboveand below discussed embodiments.

FIG. 6C shows the side cross section of one embodiment of the lead 600along line C-C of FIG. 6B. The lead 600 optionally has two sets of coils672,673 at this portion. FIG. 6D shows a pacing electrode 632 in greaterdetail. The electrode 632 optionally is partially masked with thecontact portion 636 facing outward, so that in an implanted site, theelectrode 632 contacts the vascular tissue adjacent the myocardial wall.FIG. 6E shows the side cross section of the lead along line E-E of FIG.6B, of a lead portion having one set of coils 672. FIG. 6F shows oneembodiment of electrode 634 in greater detail, showing a partiallymasked electrode 634 with the contact portion 638 facing inward. FIG. 6Gshows the side cross section of the lead 600 along line G-G of FIG. 6Bshowing the end tip 690 of the lead 600.

FIG. 7 illustrates another option for a cardiac vein lead, for example,a multiple polar lead 700 adapted for use in a passageway, such as acardiac vein. In one option, a third electrode 750 is added to a bipolarconfiguration, and the lead 700 can be used to pace and sense both theatrium and the ventricle. This configuration would allow the middleelectrode 732 to be used as a common anode for both an atrial andventricular bipole. This configuration would result in a lead utilizingthe advantages of two bipole pairs with only three electrodes. Inanother option, the electrode 734 is electrically common with theelectrode 750.

The lead 700 has a proximal end (as shown at 102 of FIG. 1), andattaches to a pulse sensor and generator (as shown at 140 of FIG. 1).The lead body 720 is cylindrical in shape and includes one or moreelectrical conductors. The electrical conductors are made of a highlyconductive, highly corrosion-resistant material. The one or moreelectrical conductors carry current and signals between the pulse sensorand generator and the electrodes 732, 734 and 750. In one embodiment,the electrode 734, for example, a full ring electrode, serves as ground.The electrode 732 is a half ring electrode and serves as an atrialelectrode. In another option, the electrode 750 is a PICOTIP (™)electrode, and also comprises a ventricular electrode.

FIG. 8 shows a miniaturized high impedance PICOTIP (™) electrode 850constructed and arranged to be a side mounted electrode, which can beused with any of the leads discussed herein. This miniaturized electrode850 increases electrode impedance by using a smaller exposed area.Electrode 850 comprises an electrode mesh 852 which increases chroniclead stability by providing local tissue ingrowth into the electrodemesh. In another embodiment, the PICOTIP (™) electrode protrudes fromthe lead body to enhance intimate wall contact.

A lead according to the coronary vein leads described herein isimplanted in any suitable manner, for example, as follows. Venous accessis obtained via the subclavian, cephalic or jugular vein. A standardstylet is inserted into the lead to straighten it and provide stiffnessfor insertion of the lead into the vasculature. The coronary vein leadwill then be guided into the coronary sinus/great cardiac vein. Once thecoronary vein lead is positioned, the stylet will be removed. Thepreferred position for coronary vein lead placement is, in one option,to place the tip of the coronary vein lead near the origin of the greatcardiac vein just proximal to the point where it originates from theinterventricular vein. This will position the pacing electrodes near theend of the coronary sinus.

The lead is tested for P-wave, P/R ratio and atrial and ventricularthreshold. The lead will be manipulated and repositioned to maximizeP-Wave and P/R ratios, and minimize atrial voltage threshold. Targetthresholds will be below 2.0 volts with a P-wave above 2 mVolts and aP/R ratio above 2. An optional method for implanting these leads is touse an “over the wire” method, for example, with an open lumen lead.This involves (1) placing a guide catheter into the coronary sinus (2)threading a guide wire into the coronary veins, and (3) pushing the leadover the guide wire.

Two other design features are described herein which improve theimplantability and the chronic performance of leads. First, it was foundthat a slender distal tubing or stylet/conductor coil section wasinstrumental in improving the ability of the medical personnel toposition these leads. It is believed that this feature provided thedistal portion of the lead with a guiding means that easily followed thevasculature. This was accomplished only when the diameter of thisguiding section was considerably less than that of the vasculature. Inone embodiment shown at FIG. 9, a lead body 920 having a taperedflexible distal tip 990 at its distal portion 904 is shown which allowsfor easier access to distal veins. The outer diameter of the lead body920 tapers from the proximal portion 902 to the distal tip 990 of thedistal portion 904. The tapered lead body provides a smaller outerdiameter at the distal tip 990, and allows more easy access to thedistal veins, which have a decreasing inner diameter, and can be morecomplex. In one option, the taper of the lead body reduces the outerdiameter by 30-70% at the distal tip 990.

Referring to FIG. 10A, a lead is shown generally at 1000. The lead 1000provides ventricular pacing and sensing with or without atrial pacingand sensing. In another option, the lead 1000 provides atrial pacing andsensing with or without ventricular pacing and sensing. In yet anotheroption, the lead 1000 provides ventricular pacing and sensing with orwithout sided defibrillation. The lead 1000 has a proximal end showngenerally at 1002 and a distal end shown generally at 1004. The lead1000 has a connector terminal 1010 at its proximal end and a lead body1020, and is constructed and arranged for insertion into the coronarysinus. The lead 1000 attaches to a pulse sensor and generator. The leadbody 1020 has multiple electrodes. Proximal ring electrodes 1006 and1008 are provided for atrial or ventricular sensing and distalelectrodes 1012 and 1014 are provided for ventricular sensing andpacing. Connector terminal 1010 electrically connects the variouselectrodes and conductors within the lead body to the pulse sensor andgenerator. The pulse sensor and generator also contains electronics tosense various pulses of the heart and also produce pulsing signals fordelivery to the heart. The pulse sensor and generator 1040 also containselectronics and software necessary to detect certain types ofarrhythmias and to correct for them. Physicians are able to program thepulse sensor and generator to correct a particular arrhythmia that thepatient may have. It should be noted that there are numerous types ofconnector terminals which connect to a pulse sensing and generating unit1040.

In use, the distal end 1004 of the lead 1000 is placed far enough intothe coronary venous system to stimulate the ventricle, as shown forexample, in FIG. 3B. This stimulation may occur at the base of theventricle, the middle ventricle or the apex of the ventricle.

In one embodiment, the lead 1000 is instantiated only for pacing andsensing purposes, and the lead 1000 may have unipolar or bipolar distalelectrodes. Referring to FIG. 10B, in one embodiment, the lead 1000 hasmultiple pairs of distal electrodes for multisite ventricular pacing.Electrodes 1046 and 1048 form an electrode pair located in the coronarysinus/great cardiac vein, and electrodes 1050 and 1052 form an electrodepair located in the ventricular portion of the lead 1000, implanted inthe coronary venous system. Electrodes 1054 and 1056 also form anelectrode pair located on the ventricular portion of the lead 1000implanted in the coronary venous system. The embodiment shown at FIG.10B may have a lead body made of a biocompatible material having shapememory characteristics such that it will return to its preformed shapeonce implanted and a stylet or guidewire is removed. An example of sucha material is polyether polyurethane. In addition, the lead body mayhave portions which have shape memory characteristics, comprising eithera shape memory polymer or a shape memory metal.

In one embodiment, the lead 1000 has proximal electrodes, shown at 1006and 1008 of FIG. 10A, which are either bipolar or unipolar, for sensingand/or pacing of the atrium. In one embodiment, multiple pairs ormultiple sets of electrodes may be used for bi-atrial pacing. Anoptional distal electrode 1014 of the lead 1000 serves as a distalshocking electrode for the purpose of delivering a high energy shockgreater than about 0.01 Joule to the ventricle. This distal shockingelectrode may be added to any of the lead configurations disclosedherein.

A lead 2000 constructed in accordance with another embodiment isillustrated in FIG. 11. It should be noted that the lead 2000 andfeatures thereof can be combined with the features discussed in theabove described and illustrated embodiments. The lead 2000 comprises anopen lumen lead, in one option. In another option, the lead 2000 issuitable for implantation within a body using a stylet, catheter, and/orguidewire. The lead 2000 has a lead body 2006 that extends to a distalend 2002, and has an atraumatic tip assembly 2010, as further describedbelow. The lead 2000 includes a biased portion 2030 at an intermediateportion 2004 of the lead 2000, and a non-biased portion 2032 distal tothe biased portion 2030.

The biased portion 2030 extends from a first end 2033 to a second end2034. In one option, the biased portion 2030 has a two-dimensional bias.In another option, the biased portion 2030 has a three-dimensional bias,for example, a helical shape as discussed above (See e.g. FIGS. 3B and3C). For instance, the biased portion 2030 has a helical shape with 1-2turns. In yet another option, one or more biases are formed within thebiased portion 2030. The biased portion 2030 is formed into a bias with,for example, shape memory material such that the lead body 2006 isstraightened during implantation, and biased once implanted, forexample, once the stylet is removed from the lead body 2006. One exampleof a suitable material, although not limited to such material, ispolyether polyurethane. In another option, shape memory material for theconductor can be used, such that the conductor can be formed with abias. The biased portion 2030 assists in maintaining the lead 2000within a passage, such as a cardiac vein or an artery. In addition, thebiased portion 2030 assists in enhancing tissue-electrode contact.

The lead 2000 further includes one or more electrodes 2036. For example,in one option, the one or more electrodes 2036 are disposed on the leadbody 2006 along the biased portion 2030, where the biased portion 2030would assist in fixation of the one or more electrodes 2036 and/orenhance tissue contact. In another option, the one or more electrodes2036 are disposed 120 degrees apart along the biased portion 2030, whichincreases the opportunity for the electrodes 2036 to make contact withthe myocardial wall. In another option, a steroid collar 2038 isdisposed directly adjacent to the one or more electrodes 2036, forexample, along the biased portion 2030. The biased portion 2030 furtherenhances the effectiveness of the steroid collar 2038 by biasing aportion of the steroid collar 2038 toward the tissue. In yet anotheroption, the lead 2000 further includes another electrode 2037 along thenon-biased portion 2032, and optionally another steroid collar 2039directly adjacent to the electrode 2037.

As discussed above, the lead 2000 includes an atraumatic tip assembly2010. The atraumatic tip assembly 2010 includes a flexible portion thatis significantly more flexible than the biased portion 2030. In oneoption, the flexible portion includes the tapered portion 2012. Thisallows for improved maneuverability of the lead 2000 through tortuousvasculature, and allows for the lead 2000 to be implanted more easilyand quickly than conventional leads. Furthermore, the flexible taperedportion 2012 allows for the guidewire, if used, to better guide the lead2000 without interference from the biased portion 2030. In one option,the flexible portion is premolded and bonded to the remaining portion ofthe lead 2000 that forms a sub-assembly. In another option, thesubassembly is placed within a mold, and the remaining portion of thelead 2000 is molded thereon.

The tapered portion 2012 begins, in one option, at the distal end 2002of the lead body 2006 and extends to the intermediate portion 2004 ofthe lead 2000 and ends at 2005. Disposed between 2005 and the biasedportion 2030 is a portion 2007 that extends, in one option, for a lengthof 5-10 cm, which further assists in the maneuverability of the lead2000. In another option, the tapered portion 2012 begins at the distalend 2002 of the lead body 2006 and extends until the biased portion 2030of the lead body 2006. The length 2014 of the tapered portion 2012, inanother option, is 1-2 cm. The tapered portion 2012 assists in allowingfor the lead body 2006 to more easily traverse vessels that generallynarrow, make tight turns, and frequently branch off. It should be notedthat the flexible portion can have a length that is different than thetapered portion 2012.

The lead 2000 further includes at least one conductor 2020. The at leastone conductor 2020, in one option, does not extend to the distal end2002 of the lead body 2006. In another option, the at least oneconductor 2020 terminates between the most distal electrode and thedistal end 2002 of the lead body 2006. This allows for enhancedflexibility of the atraumatic tip assembly 2010, where the distalportion includes all, for example, rubber material without any rigidityfrom the conductors. The conductor further assists in the transition,and the flexibility between the intermediate lead body and the taperedportion of the lead portion. In one option, the at least one conductor2020 terminates at 2022 along a portion of the tapered portion 2012 ofthe lead body 2006. In another option, the at least one conductor 2020terminates at 2024, that is proximal to the tapered portion 2012, asshown in FIG. 12. In this configuration, no conductor 2020 would bepresent along the tapered portion 2012, allowing for enhancedflexibility of the tapered portion 2012. In another option, theconductor 2020 comprises one or more coiled wires, having an innerdiameter. The inner diameter, optionally, is isodiametric along theentire length of the conductor 2020, providing for further options withrespect to flexibility for the atraumatic tip assembly 2010

During placement of a lead, a physician will often use the distal end ofthe conductor under fluoroscope to determine the placement of the leadwithin a patient. However, given the new atraumatic tip assembly 2010 asshown in FIG. 11, a physician may not be able to rely on this toestablish the location of the distal end of the lead 2000. Thus, thelead 2000 further includes, in one option, radiopaque materials withinthe lead body 2006, for example incorporated into the lead body 2006 atthe distal end 2002 of the lead body 2006. In another option, apre-molded tip assembly is formed of rubber, or other flexible material,filled with radiopaque material, where optionally the entire taperedportion is formed of the filled material 2007, as shown in FIG. 13. Thelead body 2006 is formed of a flexible material, such as, but notlimited to, LSR or Gumstock. Examples of radiopaque materials include,but are not limited to, barium sulfate, bismuth subcarbonate, tungstenpowder, platinum powder, platinum/iridium alloy powder, or a Pt Irmarker band. Varying the material selection of the lead body 2006 forthe atraumatic tip assembly 2010 will allow for providing a moreflexible atraumatic tip assembly 2010. Wall thicknesses for embodimentsincluding radiopaque materials may need to be increased fromabove-discussed embodiments. In addition, having the radiopaque materialat the distal end 2002 of the lead body 2006 will allow for a physicianto more accurately determine the location of the lead 2000 within apassage of a body.

The lead advantageously allows for effective use of a biased portion ona lead body in combination with an atraumatic tip assembly. The biasedportion allows for gentle and effective forces against passage wallsenabling the lead to be positionally maintained therein. In addition,the biased portion ensures the electrode is placed up against thepassage wall with sufficient force. The spacing of the electrodes alongthe biased portion provides for an increased opportunity for theelectrode to be placed against the passage wall. The atraumatic tipassembly is extremely flexible, relative to the biased portion, whichallows for improved maneuverability of the lead through tortuousvasculature, and allows for the lead to be implanted more easily andquickly than conventional leads. Furthermore, the flexible taperedportion of the atraumatic tip assembly allows for the guidewire orstylet, if used, to better guide the lead without interference from thebiased portion.

The leads described herein provide several advantages over previousleads. The leads provide, in one option, the ability to sense and pacethe heart using leads positioned within the cardiac vasculature, andfurther the leads provide the ability to pace and/or sense the leftheart. It has been found that by placing a therapeutic lead near theatrium, but not in the atrium, higher amplitude electrograms may bedetected as compared to a standard endocardial lead. Further, it hasbeen found that left sided pacing may help suppress atrial arrhythmias,particularly those originating near the left atrium. Still further, ithas been found that the ability to critically control the timing betweenpacing the atria and ventricles of the heart is of utility in optimizingpacing therapies. The leads described herein involve geometries thatutilize the shape of the local vasculature, the shape of the heart, orboth, to help insure that an optimally positioned lead will remain inthat position well beyond the time of implant. The lead designsdiscussed herein yield reliable and optimal performance in sensing andpacing of the heart. New coronary lead configurations are provided whichcan provide dual chamber pacing and/or defibrillation on a single leadbody.

Further provided herein is a method for placing a lead into a coronaryvein to provide sensing and pacing of the heart, for example, the leftside of the heart. In one embodiment, a lead is provided that is a rightside lead and is placed within the coronary sinus, and is then advancedfrom the coronary sinus toward the left atrium to provide left sidedsensing and pacing.

In another embodiment, a method includes placing a guidewire within oneor more passageways of a body, and threading a lead assembly over theguidewire. It should be noted that the lead assembly can be threadedover the guidewire first, and then placed in a patient, or vice versa.The lead assembly includes a lead body adapted to carry signals, wherethe lead body has a proximal end and a distal end, and an intermediateportion therebetween. The lead assembly further includes a connectorlocated at the proximal end of the lead body, and at least one conductoris disposed within the lead body. The lead body has at least onepreformed biased portion at an intermediate portion of the lead body,and a flexible portion and a tapered portion are disposed between thebiased portion and the distal end of the lead body. The tapered portionis distal to the biased portion and is more flexible than the biasedportion. The method further includes biasing one or more electrodesagainst a wall of at least one of the passageways, and placing thedistal end in a cardiac vein.

Several options for the method are as follows. For instance, in oneoption, the method further includes viewing the distal tip assemblyunder fluoroscopy, where the lead assembly includes a distal tipassembly including a premolded portion filled with radiopaque material.In another option, the method further includes flexing the distal end ofthe lead body. Optionally, biasing the electrodes against the wall ofthe passageway includes positioning one or more electrodes around ahelical portion of the lead body.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Many other embodiments will beapparent to those of skill in the art upon reading and understanding theabove description. It should be noted that embodiments discussed indifferent portions of the description or referred to in differentdrawings can be combined to form additional embodiments of the presentinvention. The scope of the invention should, therefore, be determinedwith reference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

What is claimed is:
 1. An implantable medical lead for implantationwithin a body vessel, comprising: a lead body having a proximal end andan open distal end, and including a pre-formed biased portion betweenthe proximal and distal ends, and an-unbiased portion extending distallyfrom the pre-formed biased portion, wherein the pre-formed biasedportion is adapted to fixate the lead against an interior wall of a bodyvessel upon implantation and includes a three-dimensional bias having ahelical shape; a connector configured for coupling the lead to animplantable pulse generator; a plurality of electrodes on the lead bodyin the pre-formed biased portion; an electrode on the lead body in theun-biased portion; a first conductor extending within the lead body fromthe proximal end toward the distal end and coupled to the electrode inthe un-biased portion; a plurality of second conductors extending withinthe lead body from the proximal end toward the distal end, each of thesecond conductors coupled to a respective one of the plurality ofelectrodes in the pre-formed biased portion; and an open lumen extendinglongitudinally through the distal end of the lead body.
 2. The lead ofclaim 1, wherein the lead terminates in a distal tip, and wherein thefirst conductor terminates proximal to the distal tip.
 3. The lead ofclaim 2, further comprising an unbiased, flexible tapered portionterminating at the distal tip of the lead.
 4. The lead of claim 1,wherein the lead is an over the wire lead configured for use over aguidewire or stylet.
 5. The lead of claim 1, wherein each of theelectrodes in the pre-formed biased portion include a masked electrodeportion on an inside radius of the lead body and an unmasked electrodeportion on an outside radius of the lead body.
 6. An implantable medicallead, comprising: a lead body having a proximal end and an open distalend, and including a pre-formed biased portion between the proximal anddistal ends, the pre-formed biased portion adapted to fixate the leadagainst an interior wall of a body vessel upon implantation andincluding a three-dimensional bias and a two-dimensional bias; aconnector configured for coupling the lead body to an implantable pulsegenerator; an electrode on the lead body; a conductor coil coupled tothe electrode and extending within the lead body from the proximal endtoward the distal end; and an open lumen extending longitudinallythrough the distal end of the lead body.
 7. The lead of claim 6, furthercomprising an unbiased, flexible tapered portion terminating at a distaltip of the lead.
 8. The lead of claim 6, wherein the three-dimensionalbias has a helical shape, and wherein the two-dimensional bias has aJ-shape.
 9. The lead of claim 6, wherein the conductor coil defines atleast a portion of the lumen.
 10. The lead of claim 9, wherein the leadterminates in a distal tip, and wherein the conductor coil terminatesproximal to the distal tip.
 11. The lead of claim 10, further comprisingan unbiased, flexible tapered portion terminating at the distal tip ofthe lead.
 12. The lead of claim 6, wherein the electrode is locatedwithin the three-dimensional bias.
 13. The lead of claim 6, wherein theelectrode is located within the two-dimensional bias.
 14. The lead ofclaim 6, further comprising a plurality of electrodes, wherein at leastone electrode is located distal to the pre-formed biased portion. 15.The lead of claim 6, wherein the electrode comprises a masked electrodeportion on an inside radius of the lead body and an unmasked electrodeportion on an outside radius of the lead body.
 16. An implantablemedical lead for implantation within a body vessel, comprising: a leadbody having a proximal end and an open distal end, and including apre-formed biased portion between the proximal and distal ends, andan-unbiased portion extending distally from the pre-formed biasedportion, wherein the pre-formed biased portion is adapted to fixate thelead against an interior wall of a body vessel upon implantation andincludes a three-dimensional bias having a helical shape; at least oneelectrode located at the pre-formed biased portion and arranged toprovide sensing or stimulation at a first contact location of the bodyvessel when implanted; at least one electrode located at the un-biasedportion and arranged to provide sensing or stimulation at a secondcontact location of the body vessel spaced apart from the first contactlocation when implanted; and an open lumen extending longitudinallythrough the distal end of the lead body.
 17. The lead of claim 16,further comprising a first conductor extending within the lead body fromthe proximal end toward the distal end and coupled to the at least oneelectrode located at the un-biased portion.
 18. The lead of claim 17,wherein the at least one electrode located at the pre-formed portioncomprises a plurality of electrodes, and further comprising a pluralityof second conductors extending within the lead body from the proximalend toward the distal end, each of the second conductors coupled to arespective one of the plurality of electrodes at the pre-formed biasedportion.
 19. The lead of claim 17, wherein the lead terminates in adistal tip, and wherein the first conductor terminates proximal to thedistal tip.
 20. The lead of claim 19, further comprising an unbiased,flexible tapered portion terminating at the distal tip of the lead. 21.The lead of claim 16, wherein the lead is an over the wire leadconfigured for use over a guidewire or stylet.
 22. The lead of claim 16,wherein each electrode at the pre-formed biased portion include a maskedelectrode portion on an inside radius of the lead body and an unmaskedelectrode portion on an outside radius of the lead body.